Tornier Flex Shoulder System DWF605BRecalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 03700434021592), received between Feb 7, 2022 and May 20, 2026 — classified as 25 injuries.

The most frequently reported specific device problem is “Unstable” (5 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 25 reports, in the reporter's own words as published by the FDA.

• InjuryMay 20, 2026Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE SHOULDER JOINT REPLACEMENT. THE REPORT DETAILS ANALYSIS PROVIDED FOR REVISION PROCEDURES OF MONTHLY REPORT OF APRIL 2026 DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2026, A PATIENT REQUIRED REVISION SURGERY DUE TO INFECTION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Unspecified Infection

  MAUDE report 25229279 ↗
• InjuryApr 29, 2026Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE SHOULDER JOINT REPLACEMENT. THE REPORT DETAILS ANALYSIS PROVIDED FOR REVISION PROCEDURES PERFORMED UNTIL (B)(6) 2026. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT A PATIENT REQUIRED REVISION SURGERY DUE TO INFECTION, LYSIS OF HUMERUS AND GLENOID, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 25030510 ↗
• InjuryApr 28, 2026Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE SHOULDER JOINT REPLACEMENT. THE REPORT DETAILS ANALYSIS PROVIDED FOR REVISION PROCEDURES PERFORMED UNTIL (B)(6) 2026. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT A PATIENT REQUIRED REVISION SURGERY DUE TO PERIPROSTHETIC FRACTURE ON THE HUMERAL SIDE, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Bone Fracture(s)

  MAUDE report 25016257 ↗
• InjuryFeb 16, 2026Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE SHOULDER JOINT REPLACEMENT. THE REPORT DETAILS ANALYSIS PROVIDED FOR REVISION PROCEDURES PERFORMED UNTIL (B)(6) 2024. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2024 A PATIENT REQUIRED REVISION SURGERY DUE TO INFECTION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Unspecified Infection

  MAUDE report 24342224 ↗
• InjuryOct 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE SHOULDER JOINT REPLACEMENT. THE REPORT DETAILS ANALYSIS PROVIDED FOR REVISION PROCEDURES PERFORMED UNTIL (B)(6) 2025. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT A PATIENT REQUIRED REVISION SURGERY DUE TO IMPINGEMENT AND MALPOSITION OF THE HUMERUS, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Joint Impingement

  MAUDE report 23335096 ↗
• InjuryOct 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, THE REVISION SURGERY OF SHOULDER WAS NEEDED AFTER INFECTION OF SHOULDER IMPLANT. IT WILL BE 2 STAGE REVISION. POST THIS REVISION THE SPACER HAS BEEN LEFT IN PATIENT.

  Patient problems: Bacterial Infection; Unspecified Infection

  MAUDE report 23208719 ↗
• InjuryJul 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REVISION SURGERY WAS PERFORMED DUE TO ALLEGED PATIENT PAIN AND SUPERIOR MIGRATION OF THE GLENOID IMPLANTS.

  Patient problems: Pain

  MAUDE report 22383469 ↗
• InjuryFeb 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE SHOULDER REPLACEMENT. THE REPORT DETAILS ANALYSIS PROVIDED FOR REVISION PROCEDURES PERFORMED UNTIL (B)(6) 2025. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2024 A PATIENT REQUIRED REVISION SURGERY DUE TO STIFFNESS WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER. REVISION PROCEDURE TYPE: REVISION STEMMED TOTAL REVERSE ARTHROPLASTY.

  Patient problems: Loss of Range of Motion

  MAUDE report 21433418 ↗
• InjurySep 25, 2024Unstable; Device Dislodged or Dislocated; Unstable; Device Dislodged or Dislocated

  AS REPORTED: "STUDY: SHOUT SUBJECT: (B)(6) POST-OPERATIVE AE: : INSTABILITY ¿ DISLOCATION SUBJECT LIFTED LARGE WATER BOTTLE ON (B)(6) 2024 AND FELT A POP. IMAGING SHOWED DISLOCATED RSA. PATIENT REQUIRED REVISION SURGERY. RE-OPERATION WITH COMPONENT CHANGE ON (B)(6) 2024".

  Patient problems: Joint Laxity; Subluxation

  MAUDE report 20298693 ↗
• InjurySep 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES WITH THE TORNIER SHOULDER SYSTEM. THE REPORT DETAILS ANALYSIS PROVIDED FOR PROCEDURES PERFORMED BETWEEN APRIL 2012 ¿ MAY 2022. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2021 A PATIENT REQUIRED REVISION SURGERY DUE TO INFECTION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER. REVISION PROCEDURE TYPE: DEBRIDEMENT AND IMPLANT RETENTION (DAIR).

  Patient problems: Unspecified Infection

  MAUDE report 20144460 ↗
• InjuryAug 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES WITH THE TORNIER SHOULDER SYSTEM. THE REPORT DETAILS ANALYSIS PROVIDED FOR PROCEDURES PERFORMED BETWEEN APRIL 2012 ¿ MAY 2022. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2021 A PATIENT REQUIRED REVISION SURGERY DUE TO INFECTION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER. REVISION PROCEDURE TYPE: STAGE 1 OF 2 STAGE REVISION.

  Patient problems: Unspecified Infection

  MAUDE report 19918873 ↗
• InjuryJul 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE EXPLANT WAS DUE TO AN INFECTION. THE INFECTION WAS DETECTED DURING A POST-OP FOLLOW-UP AND LOCALIZED IN THE ANTERIOR INFERIOR DELTOPECTORAL INCISION. THE MICROORGANISM IDENTIFIED WAS C. ACNES. THE PATIENT HAD NO PRIOR INFECTIONS NEAR THE SURGERY SITE. THE STERILE BARRIER OF THE DEVICE PACKAGE WAS NOT COMPROMISED, AND NO RE-STERILIZATION OF THE DEVICE WAS PERFORMED BEFORE SURGERY. NO ENVIRONMENTAL MONITORING ALERTS RELATED TO THE DEVICE¿S STORAGE WERE RECORDED. THE INFECTION WAS RESOLVED BY PROSTHESIS EXPLANTATION AND INSERTION OF AN ANTIBIOTIC CEMENT SPACER. THE SURGEON NOTICED MILD INFLAMMATION AND REFERRED THE PATIENT TO INFECTIOUS DISEASE FOR ANTIBIOTICS.

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 19757558 ↗
• InjuryFeb 2, 2024Unstable; Unstable

  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES WITH THE TORNIER SHOULDER SYSTEM. THE REPORT DETAILS ANALYSIS PROVIDED FOR PROCEDURES PERFORMED BETWEEN (B)(6)2012 ¿ (B)(6) 2022. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2019 A PATIENT REQUIRED REVISION SURGERY DUE TO INSTABILITY, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Joint Laxity

  MAUDE report 18636556 ↗
• InjuryJan 26, 2024Unstable; Unstable

  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES WITH THE TORNIER SHOULDER SYSTEM. THE REPORT DETAILS ANALYSIS PROVIDED FOR PROCEDURES PERFORMED BETWEEN (B)(6) 2012 ¿ (B)(6) 2022. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2018 A PATIENT REQUIRED REVISION SURGERY DUE TO INSTABILITY, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Joint Laxity; Subluxation

  MAUDE report 18592045 ↗
• InjuryDec 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES WITH THE TORNIER SHOULDER SYSTEM. THE REPORT DETAILS ANALYSIS PROVIDED FOR PROCEDURES PERFORMED BETWEEN APRIL 2012 ¿ MAY 2022. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2019 A PATIENT REQUIRED REVISION SURGERY DUE TO PERIPROSTHETIC FRACTURE, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER. REVISION PROCEDURE TYPE: SINGLE STAGE REVISION.

  Patient problems: Limb Fracture

  MAUDE report 18414539 ↗
• InjuryNov 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES WITH THE TORNIER SHOULDER SYSTEM. THE REPORT DETAILS ANALYSIS PROVIDED FOR PROCEDURES PERFORMED BETWEEN (B)(6) 2012 ¿ (B)(6) 2022. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2020 A PATIENT REQUIRED REVISION SURGERY DUE TO PERIPROSTHETIC FRACTURE, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER. REVISION PROCEDURE TYPE: SINGLE STAGE REVISION.

  Patient problems: Limb Fracture

  MAUDE report 18110707 ↗
• InjuryAug 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES WITH THE TORNIER SHOULDER SYSTEM. THE REPORT DETAILS ANALYSIS PROVIDED FOR PROCEDURES PERFORMED BETWEEN APRIL 2012 ¿ MAY 2022. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON 13 APRIL 2022 A PATIENT REQUIRED REVISION SURGERY DUE STIFFNESS AND UNEXPLAINED PAIN, EVENT WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Implant Pain; Loss of Range of Motion

  MAUDE report 17599374 ↗
• InjuryAug 22, 2023Break; Fracture; Break; Fracture

  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES WITH THE TORNIER SHOULDER SYSTEM. THE REPORT DETAILS ANALYSIS PROVIDED FOR PROCEDURES PERFORMED BETWEEN (B)(6) 2022. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2019 A PATIENT REQUIRED REVISION STEMMED TOTAL REVERSE ARTHROPLASTY DUE TO IMPLANT FRACTURE, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Failure of Implant

  MAUDE report 17599257 ↗
• InjuryJul 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT PRESENTED WITH AN ANTERIOR GLENOHUMERAL MASS. THE PATIENT ALSO PRESENTED WITH SWELLING IN THE FRONT OF THE SHOULDER. MRI REVEALED A MASS. THE SUBJECT WAS REFERRED OUT TO AN ORTHOPEDIC ONCOLOGIST.

  Patient problems: Seroma; Swelling/ Edema

  MAUDE report 17396593 ↗
• InjuryJul 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IS EXPERIENCING HETEROTOPIC OSSIFICATION. THE PATIENT'S SHOULDER HAS SOME LATERAL CORTEX DEFORMITY AND OSTEOLYSIS ALONG THE LATERAL METAPHYSEAL SECTION OF THE COMPONENT WITH SUPERIOR HUMERAL MIGRATION AND SEVERE GLENOID EROSION.

  Patient problems: Erosion; Osteolysis

  MAUDE report 17366790 ↗
• InjuryJan 19, 2023Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SHOULDER INSTABILITY AND A SMALL CYST ON THE SHOULDER IN (B)(6) 2022. THE PATIENT PRESENTED FOR ULTRASOUND/BIOPSY ON (B)(6) 2022. ON (B)(6) 2022 POST OP INFECTION WAS CONFIRMED. THE PATIENT UNDERWENT A REVISION PROCEDURE TO EXPLANT THE SYSTEM AND REPLACE IT WITH A SPACER.

  Patient problems: Bacterial Infection; Cyst(s); Joint Laxity; Unspecified Infection

  MAUDE report 16210601 ↗
• InjuryJul 21, 2022Unstable; Unstable

  PATIENT UNDERWENT SHOULDER HEMI-ARTHROPLASTY SEVERAL YEARS AGO. PATIENT PRESENTED TO SURGEON SEVERAL MONTHS AGO WITH INCREASING PAIN & INSTABILITY IN PROSTHETIC SHOULDER JOINT. PATIENT NOW REQUIRES CONVERSION OF HEMI-ARTHROPLASTY TO A REVERSE SHOULDER ARTHROPLASTY, DUE TO SHOULDER INSTABILITY SECONDARY TO RUPTURE OF SUBSCAPULARIS TENDON / MUSCLE (ACCORDING TO SURGEON).

  Patient problems: Failure of Implant; Implant Pain; Joint Laxity; Rupture

  MAUDE report 15075740 ↗
• InjuryJun 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT SUFFERED AN INFECTION FOLLOWING A SHOULDER REPLACEMENT SURGERY. THE PATIENT UNDERWENT A REVISION SURGERY.

  Patient problems: Bacterial Infection

  MAUDE report 14621760 ↗
• InjuryFeb 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STRYKER REPRESENTATIVE CONTACTED COMPLAINT HANDLING TEAM AND REPORTED THE FOLLOWING ISSUE: "PATIENT (B)(6) UNDERWENT A REVISION SURGERY DUE TO DEEP INFECTION. REMOVAL OF AEQUALIS ASCEND FLEX HUMERAL COMPONENTS (STEM AND INSERT) AND AEQUALIS REVERSED GLENOID SPHERE." 1ST REVISION SURGERY.

  Patient problems: Bacterial Infection; Unspecified Infection

  MAUDE report 13486167 ↗
• InjuryFeb 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT (B)(6) HAD A POST-OPERATIVE COMPLICATION: DEEP INFECTION. "PATIENT COMPLAINING OF ONGOING PAIN- CT ASPIRATION WAS POSITIVE FOR C ACNES" PATIENT WILL SCHEDULE REVISION SURGERY. (THE ADVERSE EVENT WAS IDENTIFIED AS NOT RELATED TO THE STUDY DEVICE AND POSSIBLY RELATED TO THE SURGICAL PROCEDURE).

  Patient problems: Bacterial Infection; Implant Pain

  MAUDE report 13470676 ↗